K934790 is an FDA 510(k) clearance for the SEPP ADHESIVE REMOVER, a Solvent, Adhesive Tape (Class I — General Controls, product code KOX), submitted by Medi-Flex Hospital Products, Inc. (Overland Park, US). The FDA issued a Cleared decision on March 11, 1994, 157 days after receiving the submission on October 5, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4730.
| 510(k) Number | K934790 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 05, 1993 |
| Decision Date | March 11, 1994 |
| Days to Decision | 157 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | KOX — Solvent, Adhesive Tape |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4730 |